Xenotransplantation moving to human trials for kidney/heart
FDA authorized human clinical trials of gene-edited pig kidneys from eGenesis and United Therapeutics in 2025, with trials now enrolling. First formal xenotransplant trials represent a paradigm shift but face 12-24 month path to safety data that could trigger broader biotech rotation.
Why then
- +eGenesis kidney trial enrolling 3 patients with FDA authorization as of 2025
- +United Therapeutics planning 6-patient trial with potential expansion to 50
- +Mass General performed second eGenesis pig kidney transplant in January 2025
Risks
- −Patient deaths or severe rejection in early trials killing the field
- −Porcine virus transmission creating safety crisis
- −Ethical/religious objections limiting adoption even if successful